Treatment Clinical Trial
Official title:
Randomized Clinical Trial Comparing Treatment of Tretinoin or Superficial Dermabrasion for Recent Stretch Marks
NCT number | NCT01027793 |
Other study ID # | 11-CBED08-01 |
Secondary ID | |
Status | Completed |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | March 2009 |
Est. completion date | August 2010 |
Verified date | January 2021 |
Source | Brazilan Center for Studies in Dermatology |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study aims to evaluate head-to-head the effectiveness of tretinoin 0.5% and superficial dermabrasion in subjects that have recent stretch marks.
Status | Completed |
Enrollment | 32 |
Est. completion date | August 2010 |
Est. primary completion date | August 2010 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 11 Years to 25 Years |
Eligibility | Inclusion Criteria: - Female subjects, aged between 11 and 25 years - Female subjects of childbearing age that present a negative urine pregnancy test and are using an effective contraceptive method for at least 3 months prior the study - Subjects that have thin (1-5mm) recent(less than 6 months of evolution),reddish or purple line stretch marks. The striae should be symmetrical and it could be located in the abdomen,breasts, upper arms, thighs (both inner and outer), hips, and buttocks - Subjects agreeing to take part of the study, after being fully informed of the purpose and the nature of the investigation and after having signed the informed consent form - Subjects with sufficient schooling and awareness to enable them to cooperate to the degree required by this protocol - Subjects who had never received treatment for striae in the studied area Exclusion Criteria: - Subjects whose medical history and physical examination present clinical pathology, as marfan Syndrome, cushing, systemic autoimmune or neurological diseases - Pregnant or women in breastfeeding, or women planning to become pregnant - Previous treatment for striae in the local area of the study. - Subjects that are in use of tretinoin or glycolic acid in the local area of the study. - Presence of white striae in the local area of the study - History of Connective Tissue Disease - History of keloid development or skin healing problems - Subjects that are taking medications associated with striae development, as systemic corticosteroids, indinavir, hormonal replacement therapy - Hypersensibility to retinoic acid - Subjects who intend to get tan in the area of the study, through exposure of sun or tanning machines during the study - Subjects that have a variation in their weight of more than 2 kg in a period of four months prior the study - Predisposition for chronic inflammatory process - Subjects with chronic diseases as diabetes, cardiopathy, neoplasm, HIV and autoimmune diseases (vitiligo, lupus) |
Country | Name | City | State |
---|---|---|---|
Brazil | Brazilian Center for Studies in Dermatology | Porto Alegre | Rio Grande Do Sul |
Lead Sponsor | Collaborator |
---|---|
Brazilan Center for Studies in Dermatology |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Width of Stretch Marks | Striae width was measured with Mirror Medical Imaging Software (Canfield Scientific, Inc., Parsippany, NJ) | Baseline and 16 weeks | |
Primary | Length of Stretch Marks | Striae length was measured with Mirror Medical Imaging Software (Canfield Scientific, Inc., Parsippany, NJ) | Baseline and 16 weeks | |
Secondary | Global Aesthetic Improvement Scale | Very much improved: Optimal cosmetic result for the implant in this patient
Much improved: Marked improvement in appearance from the initial condition but not completely optimal for this patient; touch-up would slightly improve the result 3 - Improved: Obvious improvement in appearance from the initial condition, but touch-up or retreatment is indicated 4 - No change: Appearance essentially the same as the original condition 5 - Worse: Appearance worse than the original condition |
16 weeks | |
Secondary | Patient Satisfaction | Patient satisfaction measured with Lickert scale (Very satisfied, Satisfied, Neither satisfied nor unsatisfied, unsatisfied, very unsatisfied) | 16 weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05243134 -
The Influence of Anatomic Deformities on the Clinical Efficacy in the Patients With Patellar Dislocation
|
||
Completed |
NCT02486874 -
Clinical Evaluation of PoreSkin
|
Phase 1 | |
Active, not recruiting |
NCT04592640 -
Stem Cells for Uremic Calciphylaxis Patients
|
N/A | |
Recruiting |
NCT04599686 -
Stereotactic Body Radiotherapy (SBRT) for Oligometastatic Prostate Cancer
|
N/A | |
Recruiting |
NCT03351842 -
Surgery With or Without Chemotherapy for Stage I NSCLC With Micropapillary Component ≥ 20%
|
Phase 2 | |
Completed |
NCT03439930 -
The Effect of Balance Training on Neuromuscular Control in Subjects With CAI
|
N/A | |
Completed |
NCT02782442 -
Cognitive Training Delivered Remotely to Individuals With Psychosis (ROAM)
|
N/A | |
Not yet recruiting |
NCT05537155 -
Buccal Acupuncture for Delirium Treatment in Older Patients Recovering From Orthopedic Surgery
|
N/A | |
Recruiting |
NCT02971982 -
PCD Versus RCD for the Treatment of Patients With Waldenstrom's Macroglobulinemia
|
Phase 1/Phase 2 | |
Completed |
NCT02820272 -
Water for Reducing Pain in Negative Pressure Wound Therapy
|
Phase 2 | |
Completed |
NCT00984958 -
Bulkamid Treatment of Stress Incontinence in Women With Urinary Stress Incontinence and Not Suitable to TVT-procedure
|
N/A | |
Completed |
NCT00575224 -
Pegasys and Copegus for Asian Patients With Treatment-naive Hepatitis C Genotypes 6, 7, 8, 9
|
Phase 4 | |
Completed |
NCT00164528 -
Intervening With Children/Adolescents With FAS/ARND
|
Phase 1/Phase 2 | |
Completed |
NCT00164307 -
Assisting Children With Prenatal Alcohol Exposure in Developing Peer Friendships
|
Phase 1/Phase 2 | |
Recruiting |
NCT04603586 -
Stereotactic Radiotherapy in Locally Advanced Pancreatic Cancer With Different Biological Effective Doses
|
N/A | |
Recruiting |
NCT03375424 -
Vedolizumab Study With Inflammatory Bowel Disease Patients in Germany
|
N/A | |
Not yet recruiting |
NCT04062370 -
Ranibizumab Treatment for Macular Edema Secondary to Retinal Vein Occlusion
|
Phase 4 | |
Not yet recruiting |
NCT02931136 -
Early Diagnosis and Early Treatment of Alzheimer's Disease Based on Senile Plaque Imaging
|
Phase 4 | |
Completed |
NCT04661228 -
Diagnostic Survey of Mental and Substance Use Disorders in HUNT (PsykHUNT)
|
||
Recruiting |
NCT03365141 -
Efficacy of Intralesional Triamcinolone Injection in the Treatment of Vitiligo
|
N/A |